Cuidad Real, Spain

  • Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients

    The study is based on the collection of blood samples and tumor sample analysis, in real world NSCLC stage IIIA/B and IIIC; PD-L1>1%; non-resectable patients on treatment with IO after cCRT without progression. The patients participating in this study will not receive treatment in relation to the study, no drugs will be provided. Patients will be treated as per standard clinical practice. All data collected for this study will be collected retrospectively from patient clinical chart. Only secondary data collected will be analyzed together will samples analysis information.The duration of the study is expected to be 3 years.

    Phase

    N/A

    Span

    161 weeks

    Sponsor

    Fundación GECP

    Ciudad Real

    Recruiting

  • PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients

    Post-market, prospective, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon therapy in real-world patients with small native vessel coronary artery disease, and to demonstrate the safety of short dual antiplatelet therapy (7 days) in high-bleeding risk patients with native small vessel coronary artery disease treated with DCB therapy. A PCI with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician. The angiographic study will be analyzed in a core lab (icicorelab) blinded to the procedural outcomes and the patients' follow-up. As per clinical practice, 1-year clinical follow-up of all the patients will be conducted with a first assessment at 30 days, a second assessment at 6 months, and one final assessment at 12 months. Should the patient have an elevated bleeding risk -defined as concomitant therapy with oral anticoagulation or a PRECISE-DAPT score ≥ 25- patients will be included in a high-bleeding risk substudy. The antiplatelet therapy regime will be administered according to the local investigator and the treating medical team.

    Phase

    N/A

    Span

    149 weeks

    Sponsor

    Fundación EPIC

    Ciudad Real

    Recruiting

  • Risk Stratification Using MEESSI-AHF Scale in ED and Impact on AHF Outcomes

    Study 1: A non-intervention study involving the consecutive inclusion of 3,200 patients with AHF in 16 Spanish EDs managed according to the usual practice. Individual risk will be retrospectively stratified according to the MEESSI-AHF scale, and we will analyze the distribution of the categories of risk in patients admitted and discharged and the prognosis of patients with low risk discharged from the ED and compare the events observed in this subgroup of patients with the recommended international standards. Study 2: This is a cuasiexperimental study in 8 EDs with consecutive inclusion of 1,600 patients with AHF managed according to the usual practice (without stratification of risk, pre-phase) and 1,600 patients managed after the implementation of the MEESSI-AHF scales for risk stratification before the final decision making in the ED (post-phase). If the patient has low risk the calculator will propose discharge; for the remaining categories of risk the calculator will propose patient admission. The final decision corresponds to the attending physician and if this decision differs from what was proposed, a reason will be given. Study 3: Open multicentre (8 EDs) randomized clinical trial (1:1) comparing the results obtained in the patients randomized to usual clinical practice (1,600 patients) with those obtained in the patients randomized to the use of the MEESSI-AHF scale for risk stratification (1,600 patients) prior to decision making. The dynamics of the decision proposed by the scale will be the same as that in Study 2. Main outcomes (Studies 1, 2, 3): Death (by any cause and cardiovascular cause) at 30 days and at 1 year; combined event (revisit to the ED or hospitalization for AHF or death) at 30 days post-discharge (global analysis of all the patients with AHF stratified by categories of risk); days alive and outside the hospital at 30 days after the index event (consultation to the ED); and proportion of patients managed without hospitalization.

    Phase

    N/A

    Span

    79 weeks

    Sponsor

    Hospital Clinic of Barcelona

    Ciudad Real

    Recruiting

  • AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)

    The WILLEM study is an investigator-initiated, multicenter, observational trial aiming to validate a cloud-based AI-powered ECG analysis platform to early diagnose and predict the behavior of cardiac abnormalities and cardiac diseases from patients admitted to cardiovascular units. Model-derived diagnosis will be compared with cardiology expert's diagnosis in a test dataset. Clinical outcomes will be included to assess model prediction capabilities: sensitivity, specificity and accuracy. In this observational study, patients will be randomly divided into two groups: (1) a training group to design new methodologies and algorithms; and (2) a test group to evaluate performance of methodologies aiming to avoid overfitting. Willem™ AI-powered ECG analysis platform supports the analysis of cardiac electrical signals ≥ 10 seconds onwards obtained from devices in-clinic (E.g., 12-lead ECG devices at hospitals or primary care, telemetries, monitors) and at-home or telemedicine interfaces (E.g., Holter devices, event recorders, 6, 3, 2, 1-lead ECG wearables, textile electrodes and patches for mobile cardiac telemetry).

    Phase

    N/A

    Span

    131 weeks

    Sponsor

    Idoven 1903 S.L.

    Ciudad Real

    Recruiting

    Healthy Volunteers

  • Sequent Extended Study

    The objective of this multicenter, prospective, non-randomized, postmarket clinical follow-up(PMCF) study is to confirm and support the clinical safety and performance of the Sequent Please Neo in a NON-SELECTED, Real Word population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device Regulation requirements for post-market clinical follow-up.

    Phase

    N/A

    Span

    118 weeks

    Sponsor

    Fundación EPIC

    Ciudad Real

    Recruiting

  • SUPRAFLEX CRUZ PMCF Study ( rEpic05 )

    The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the SUPRAFLEX CRUZ in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

    Phase

    N/A

    Span

    134 weeks

    Sponsor

    Fundación EPIC

    Ciudad Real

    Recruiting

  • Tiraglolumab Atezolizumab and Chemoradiotherapy in Localized Anal Carcinoma (TIRANUS)

    The TIRANUS trial is a Phase II, single-arm, open-label, non randomized, non controlled, proof-of-concept clinical trial of atezolizumab and tiragolumab in concomitancy with standard chemoradiotherapy (RT, 5-Fluorouracil, and Cisplatin) as first-line in localized squamous cell carcinoma of the anal canal. 1. Objectives 1.1 Primary Objectives To determine if atezolizumab plus tiragolumab in concomitancy with chemoradiotherapy is effective in achieving complete remission in patients with localized squamous cell carcinoma of the anal canal assessed by means of clinical complete response (CCR), defined as the percentage of patients who have achieved complete response (CR), disappearance of all lesions according to RECIST 1.1 criteria and no presence of residual disease assessed by biopsy at the end of consolidation phase (week 26). 1.2. Secondary Objectives Efficacy secondary objectives: - To evaluate the locoregional failure rate (LFR), defined as the percentage of patients who present progression/relapse of disease in the anal canal and/or regional organs and/or regional lymph nodes. Locoregional failure rate will be estimated using the appropriate logistic regression model at 1-year, 2-years, and 3-years after the first dose of study treatment and end of study. - To evaluate the disease-free survival (DFS) of patients with localized squamous cell carcinoma of the anal canal, defined as the time elapsed from the first dose of study treatment to progression, relapse, or death from any cause, whichever occurs first. The investigators will assess the DFS rate at 1, 2, and 3 years. The 1-year, 2-years, and 3-years DFS rates are defined as the rate of patients alive and free of relapse or progression at 1, 2, and 3 years after the first dose of study treatment respectively, estimated by Kaplan-Meier. - To evaluate the colostomy-free survival (CFS) of patients with localized squamous cell carcinoma of the anal canal, defined as the time elapsed from the first dose of study treatment to the date the colostomy was required or death from any cause, whichever occurs first. The 1-year, 2-years, and 3-years CFS rates are defined as the rate of patients alive and free of colostomy at 1, 2, and 3 years after the first dose of study treatment respectively, estimated by Kaplan-Meier. - To determine the overall survival (OS) of patients with localized squamous cell carcinoma of the anal canal, defined as the time elapsed from the first dose of study treatment until death from any cause. The investigators will assess the OS rate at 3 and 5 years. The 3-years and 5-years OS rates are defined as the rate of patients alive at 3 and 5 years after the first dose of study treatment respectively, estimated by Kaplan-Meier. Safety secondary objectives - To evaluate safety of the intended treatment regimen based on the frequency and severity of adverse events and Treatment-emergent adverse events (TEAEs) assessed by NCI CTCAE v5.0. - Health-related quality of life (HRQoL), assessed through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) version 3. Exploratory objectives - To determine molecular or clinical predictive biomarkers of clinical complete response. - To evaluate the relationship between the treatment activity and the expression of: - Immune checkpoint proteins (including but not limited to PD-1, PD-L1, CD28, OX40, CD40) - Presence of infiltrating T cell lymphocytes and immune infiltrate characterization (including but not limited to CD45, CD3, CD8, CD4, CD56, IFNbeta, STAT1, CD 163, H2AX) - T-cell clonality (TCR) by multiplex PCR-based clonality (polymerase chain reaction amplification based clonality) // NGS (Next-Generation Sequencing) - Tumor mutational burden (TMB) by means of a gene panel with >300 genes. - Presence of infections: poliovirus receptor (PVR) and human papillomavirus (HPV) - Presence of potential molecular biomarkers in ctDNA (including but not limited to HPV, KRAS, or TP53)

    Phase

    2

    Span

    281 weeks

    Sponsor

    Grupo Espanol Multidisciplinario del Cancer Digestivo

    Ciudad Real

    Recruiting

    Healthy Volunteers

  • Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial

    STEMI patients with multivessel disease planned for invasive evaluation of intermediate lesions (40-69% stenosis) are initially investigated with fractional flow reserve (FFR). Patients with FFR ≤ 0.80 are considered as screening failure and treated with PCI. Patients with FFR > 0.80 are then investigated with optical coherence tomography (OCT). Patients without OCT findings of vulnerable plaque are treated with OMT and included in the OMT registry arm. Patients presenting with OCT characteristics of vulnerable plaque are included in the randomized trial comparing PCI with stent implantation plus OMT versus OMT.

    Phase

    N/A

    Span

    305 weeks

    Sponsor

    Fundación EPIC

    Ciudad Real

    Recruiting

  • Coroflex® ISAR NEO PMCF Study

    The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system Sirolimus Eluting Stent in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

    Phase

    N/A

    Span

    183 weeks

    Sponsor

    Fundación EPIC

    Ciudad Real

    Recruiting

  • Clinical Effectiveness of Advanced Hybrid Closed-loop Systems for Achieving Time in Tight Range Among T1D Patients

    Diabetes is a chronic disease with a relevant public health burden. Type 1 diabetes (T1D) is characterized by the autoimmune destruction of insulin-producing pancreatic beta cells, which requires the administration of exogenous insulin for its treatment. Maintaining blood glucose levels as close to normal as possible is essential to avoid the associated microvascular and macrovascular complications that affect quality of life, as well as morbidity and mortality due to the deleterious long-term effects of suboptimal control. Therefore, the key to prevent and/or reduce the development of these complications lies in adequate and strict glycemic control. The use of advanced hybrid closed-loop (AHCL) systems in patients with T1D is associated with improved glycemic control and quality of life in both controlled clinical trials and real-life studies. Since 2021, AHCL systems are considered the standard of care, ahead of traditional MDI. There are three main types of AHCL systems marketed in Spain: SmartGuard in Medtronic Minimed 780G (MM780G), Control-IQ in Tandem T Slim X2 (TTSX2) and CamAPS in Ypsopump (CamAPS). All three systems have been shown indepently to significantly improve glycaemic control in people with DM1 as expressed by the classic control targets of the International Time in Range Consensus (percentage of interstitial glucose time in range 70-180 mg/dL >70%). So much so that it has been suggested to further intensify the possible glucose targets in patients treated with AHCL systems to a time in tight range (TITR) of interstitial glucose (70-140 mg/dL) >50%. However, there is little information on the benefits and safety of using tighter control targets. Furthermore, there is no evidence about comparing the clinical benefit differences between these three types of technology. The main objective is to analyze the effect on time in tight range (TiTR, 70-140 mg/dL) of interstitial glucose between three different advanced hybrid closed-loop (AHCL) systems among adult people with T1D. This is multicenter (3 centers) cross-sectional observational clinical study (non-randomized). The target population will be adult T1D patients treated with any of the aforementioned AHCL systems followed in any of the three participant centers.

    Phase

    N/A

    Span

    44 weeks

    Sponsor

    Castilla-La Mancha Health Service

    Ciudad Real

    Recruiting

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